BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 1844880 · Received September 22, 2010

    Report

    Report Number
    2210968-2010-01153
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HERNIA RECURRED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PRIMARY UMBILICAL HERNIA REPAIR ON (B)(6) 2010 AND MESH WAS PLACED. THE PT EXPERIENCED A RECURRENT HERNIA AND A REVISION WAS PERFORMED ON (B)(6) 2010. WHEN THE SURGEON INSPECTED, THE MESH THAT WAS IMPLANTED IN (B)(6) 2010, IT APPEARED "SCALY AND CRYSTALIZED." THE MESH WAS REMOVED BECAUSE, IT LOOKED LIKE IT POSSIBLY COULD HAVE BEEN INFECTED. A DIFFERENT MESH WAS IMPLANTED. CURRENTLY, THE PT HAS NO REPORTED PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA CC8CXCZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention